Specialist I, Patient Safety and Pharmacovigilance Operations

Posted 14 days ago

corcept therapeuticsRedwood City (CA)

Regulatory Affairs Specialists Pharmaceutical Preparation Manufacturing

SENIORITY

Senior

SALARY

$65,800 - $87,000 per year

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About the role

Specialist I, Patient Safety and Pharmacovigilance Operations Redwood City, California, United StatesFor more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases. Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. This role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in the postmarketing (PM) and clinical trial (CT) setting. The role is primarily responsible for the daily management of shared PSPV mailboxes and other safety intake channels, ensuring incoming communications are reviewed promptly, potential safety information is identified, and items are appropriately documented, routed, tracked, and escalated in accordance with established procedures and regulatory timelines.

Responsibilities:

Monitor and manage assigned PSPV shared mailboxes and intake channels, ensuring timely review and disposition of incoming reports and communications
Perform initial review/triage of incoming information to identify potential adverse events (AEs), serious adverse events (SAEs), product quality complaints (PQCs), special situations, and other safety-relevant information
Identify potential Individual Case Safety Reports (ICSRs) and ensure information is routed to the appropriate case-processing team or workflow within required timelines
Categorize, assign, route, file, and archive mailbox communications according to established procedures
Prioritize and escalate serious, urgent, medically significant, or time-sensitive safety information as required
Perform routine reconciliation of PSPV mailboxes and intake channels/sources to confirm potentially reportable information has been appropriately identified, received and processed
Support the development of training materials
Track and archive safety-related training for internal teams and vendors
Assist with audits, regulatory inspections, and inspection-readiness activities by providing intake records and supporting documentation, as needed
Perform additional PSPV projects and activities as assigned
Preferred Skills, Qualifications and Technical Proficiencies:
Ability to work in a dynamic environment to meet patient and corporate needs
Excellent communication skills (verbal and written)
Ability to collaborate with cross-functional teams and support multiple projects in a fast-paced environment
Able to travel for up to 10% of time
Flexibility to be in office more than 3 days week to meet any business needs (e.g., audits, regulatory inspections)

Preferred Education and Experience:

Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD1+ years in healthcare setting, pharma or biotech company
Familiarity with global pharmacovigilance regulations and safety-reporting requirements is desirable
The pay range that the Company reasonably expects to pay for this headquarters-based position is $65,800 $87,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.

Corcept is an Equal Opportunity Employer

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